AR080221A1 - IMMUNOCOMPATIBLE AMNIOTIC MEMBRANE PRODUCTS - Google Patents

IMMUNOCOMPATIBLE AMNIOTIC MEMBRANE PRODUCTS

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Publication number
AR080221A1
AR080221A1 ARP110100508A ARP110100508A AR080221A1 AR 080221 A1 AR080221 A1 AR 080221A1 AR P110100508 A ARP110100508 A AR P110100508A AR P110100508 A ARP110100508 A AR P110100508A AR 080221 A1 AR080221 A1 AR 080221A1
Authority
AR
Argentina
Prior art keywords
cells
placenta
cryopreservant
minute
minutes
Prior art date
Application number
ARP110100508A
Other languages
Spanish (es)
Inventor
Jennifer Michelle Marconi
Timothy Jansen
Samson Tom
Alla Danilkovitch
Dana Yoo
Jin-Qiang Kuang
Original Assignee
Osiris Therapeutics Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Osiris Therapeutics Inc filed Critical Osiris Therapeutics Inc
Publication of AR080221A1 publication Critical patent/AR080221A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/28—Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/10—Preservation of living parts
    • A01N1/12—Chemical aspects of preservation
    • A01N1/122—Preservation or perfusion media
    • A01N1/125—Freeze protecting agents, e.g. cryoprotectants or osmolarity regulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/48—Reproductive organs
    • A61K35/50—Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1825—Fibroblast growth factor [FGF]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1841—Transforming growth factor [TGF]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/39—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/55—Protease inhibitors
    • A61K38/57—Protease inhibitors from animals; from humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06—Animal cells or tissues; Human cells or tissues
    • C12N5/0602—Vertebrate cells
    • C12N5/0603—Embryonic cells ; Embryoid bodies
    • C12N5/0605—Cells from extra-embryonic tissues, e.g. placenta, amnion, yolk sac, Wharton's jelly
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2500/00—Specific components of cell culture medium
    • C12N2500/02—Atmosphere, e.g. low oxygen conditions
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2501/00—Active agents used in cell culture processes, e.g. differentation
    • C12N2501/10—Growth factors
    • C12N2501/115—Basic fibroblast growth factor (bFGF, FGF-2)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2502/00—Coculture with; Conditioned medium produced by
    • C12N2502/02—Coculture with; Conditioned medium produced by embryonic cells
    • C12N2502/025—Coculture with; Conditioned medium produced by embryonic cells extra-embryonic cells, e.g. amniotic epithelium, placental cells, Wharton's jelly

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Zoology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Cell Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biotechnology (AREA)
  • Organic Chemistry (AREA)
  • Reproductive Health (AREA)
  • Wood Science & Technology (AREA)
  • Pregnancy & Childbirth (AREA)
  • Genetics & Genomics (AREA)
  • Gynecology & Obstetrics (AREA)
  • Virology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Dentistry (AREA)
  • Environmental Sciences (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Materials For Medical Uses (AREA)
  • Medicinal Preparation (AREA)

Abstract

Productos placentarios que comprenden una membrana amniotica inmunocompatible. Estos productos placentarios pueden criopreservarse y contienen céluIas terapéuticas viables una vez descongelados. Los productos placentarios de la presente son utiles para promover la cicatrizacion. Reivindicacion 1: Un método para manufacturar un producto placentario, caracterizado porque comprende los siguientes pasos: a. obtener una placenta; b. eliminar selectivamente una porcion sustancial uno o más tipos de células inmunogénicas de la membrana amniotica, donde los uno o más tipos de células inmunogénicas comprenden los macrofagos CD14+ funcionales; y el paso de eliminacion selectiva conserva la viabilidad de una porcion sustancial de células terapéuticas nativas seleccionadas entre las MSC, los fibroblastos, las células epiteliales o una combinacion las anteriores; c. criopreservar la membrana amniotica en un medio de criopreservacion; y d. opcionalmente, eliminar sustancialmente la totalidad del tejido vascularizado o de las células inmunogénicas derivadas del tejido vascularizado de la placenta o de la membrana amniotica correspondiente. Reivindicacion 2: El método de la reivindicacion 1 caracterizado porque dicho paso de eliminacion comprende eliminar los trofoblastos de la membrana corionica y retener la membrana corionica. Reivindicacion 4: El método de la reivindicacion 1, caracterizado porque dicho paso de eliminacion comprende exterminar o inactivar selectivamente los macrofagos CD14+ funcionales. Reivindicacion 5: El método de la reivindicacion 4, caracterizado porque dicho paso de eliminacion comprende refrigerar la placenta durante un período de tiempo determinado antes del paso de criopreservacion. Reivindicacion 8: El método de la reivindicacion 5, caracterizado porque dicho período de tiempo es de al menos aproximadamente 10 minutos, aproximadamente 20 minutos, aproximadamente 30 minutos, aproximadamente 40 minutos o aproximadamente 50 minutos. Reivindicacion 10: El método de cualquiera de las reivindicaciones 5-9, caracterizado porque la refrigeracion comprende incubar la placenta durante dicho período de tiempo a una temperatura de entre aproximadamente -10°C y aproximadamente 15°C, o de aproximadamente 2°-8°C. Reivindicacion 11: El método de la reivindicacion 4, caracterizado porque dicho paso de eliminacion comprende tratar la placenta con un anticuerpo anti-TNF-alfa. Reivindicacion 13: El método de cualquiera de las reivindicaciones precedentes, caracterizado porque el paso de criopreservacion comprende reducir la temperatura a una velocidad menor que aproximadamente 10°C/minuto, aproximadamente 5°C/minuto, aproximadamente 3°C/minuto, aproximadamente 2°C/minuto o aproximadamente 1°C/minuto. Reivindicacion 15: El método de cualquiera de las reivindicaciones 1-12, caracterizado porque el criopreservante comprende un criopreservante que puede penetrar en las células, un criopreservante que no puede penetrar en las células o una combinacion de éstos, donde opcionalmente el criopreservante que puede penetrar en las células comprende: a. DMSO; o b. DMSO en una cantidad mayoritaria. Reivindicacion 17: El método de la reivindicacion 15, caracterizado porque el criopreservante que puede penetrar en las células comprende DMSO en una proporcion de entre aproximadamente 2% y aproximadamente 20%, entre aproximadamente 5% y aproximadamente 20%, entre aproximadamente 5% y aproximadamente 15% o entre aproximadamente 7% y aproximadamente 13%. Reivindicacion 18: El método de la reivindicacion 15, caracterizado porque el medio de criopreservacion también comprende albumina, donde opcionalmente la albumina es HSA. Reivindicacion 25: El método de cualquiera de las reivindicaciones 1-12, caracterizado porque el método comprende retener la capa basal, la capa compacta, la capa de fibroblastos y la capa esponjosa de la membrana amniotica. Reivindicacion 26: El método de la reivindicacion 25, caracterizado porque entre al menos aproximadamente 15,9% y aproximadamente 100%, entre aproximadamente 25% y aproximadamente 100%, entre aproximadamente 35% y aproximadamente 100%, entre aproximadamente 50% y aproximadamente 100%, entre aproximadamente 75% y aproximadamente 100%, entre aproximadamente 90% y aproximadamente 100%, entre aproximadamente 95% y aproximadamente 100% o sustancialmente la totalidad de las células del epitelio amniotico no son eliminadas de la placenta.Placental products comprising an immunocompatible amniotic membrane. These placental products can be cryopreserved and contain viable therapeutic cells once thawed. The placental products of the present are useful to promote healing. Claim 1: A method of manufacturing a placental product, characterized in that it comprises the following steps: a. get a placenta; b. selectively remove a substantial portion of one or more types of immunogenic cells from the amniotic membrane, where the one or more types of immunogenic cells comprise the functional CD14 + macrophages; and the selective elimination step preserves the viability of a substantial portion of native therapeutic cells selected from the MSCs, fibroblasts, epithelial cells or a combination of the foregoing; C. cryopreserve the amniotic membrane in a cryopreservation medium; and d. optionally, substantially eliminate all of the vascularized tissue or of the immunogenic cells derived from the vascularized tissue of the placenta or the corresponding amniotic membrane. Claim 2: The method of claim 1 characterized in that said elimination step comprises removing the trophoblasts from the chorionic membrane and retaining the chorionic membrane. Claim 4: The method of claim 1, characterized in that said elimination step comprises selectively killing or inactivating the functional CD14 + macrophages. Claim 5: The method of claim 4, characterized in that said elimination step comprises cooling the placenta for a certain period of time before the cryopreservation step. Claim 8: The method of claim 5, characterized in that said period of time is at least about 10 minutes, about 20 minutes, about 30 minutes, about 40 minutes or about 50 minutes. Claim 10: The method of any of claims 5-9, characterized in that the cooling comprises incubating the placenta during said period of time at a temperature between about -10 ° C and about 15 ° C, or about 2 ° -8 ° C. Claim 11: The method of claim 4, characterized in that said elimination step comprises treating the placenta with an anti-TNF-alpha antibody. Claim 13: The method of any of the preceding claims, characterized in that the cryopreservation step comprises reducing the temperature at a rate less than about 10 ° C / minute, about 5 ° C / minute, about 3 ° C / minute, about 2 ° C / minute or approximately 1 ° C / minute. Claim 15: The method of any of claims 1-12, characterized in that the cryopreservant comprises a cryopreservant that can penetrate the cells, a cryopreservant that cannot penetrate the cells or a combination thereof, where optionally the cryopreservant that can penetrate in the cells it comprises: a. DMSO; or b. DMSO in a majority amount. Claim 17: The method of claim 15, characterized in that the cryopreservant that can penetrate the cells comprises DMSO in a proportion of between about 2% and about 20%, between about 5% and about 20%, between about 5% and about 15% or between about 7% and about 13%. Claim 18: The method of claim 15, characterized in that the cryopreservation medium also comprises albumin, where the albumin is optionally HSA. Claim 25: The method of any of claims 1-12, characterized in that the method comprises retaining the basal layer, the compact layer, the fibroblast layer and the spongy layer of the amniotic membrane. Claim 26: The method of claim 25, characterized in that between at least about 15.9% and about 100%, between about 25% and about 100%, between about 35% and about 100%, between about 50% and about 100 %, between about 75% and about 100%, between about 90% and about 100%, between about 95% and about 100% or substantially all of the amniotic epithelial cells are not removed from the placenta.

ARP110100508A 2010-02-18 2011-02-18 IMMUNOCOMPATIBLE AMNIOTIC MEMBRANE PRODUCTS AR080221A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US33846410P 2010-02-18 2010-02-18
US33848910P 2010-02-18 2010-02-18
US36956210P 2010-07-30 2010-07-30

Publications (1)

Publication Number Publication Date
AR080221A1 true AR080221A1 (en) 2012-03-21

Family

ID=44476694

Family Applications (6)

Application Number Title Priority Date Filing Date
ARP110100505A AR080218A1 (en) 2010-02-18 2011-02-18 IMMUNOCOMPATIBLE CORIONIC MEMBRANE PRODUCTS
ARP110100509A AR080222A1 (en) 2010-02-18 2011-02-18 THERAPEUTIC PRODUCTS THAT INCLUDE VITALIZED PLACENTARY DISPERSIONS
ARP110100508A AR080221A1 (en) 2010-02-18 2011-02-18 IMMUNOCOMPATIBLE AMNIOTIC MEMBRANE PRODUCTS
ARP110100510A AR080223A1 (en) 2010-02-18 2011-02-18 THERAPEUTIC PRODUCTS THAT INCLUDE VITALIZED PLACENTARY DISPERSIONS
ARP110100507A AR080220A1 (en) 2010-02-18 2011-02-18 IMMUNOCOMPATIBLE AMNIOTIC MEMBRANE PRODUCTS
ARP110100506A AR080219A1 (en) 2010-02-18 2011-02-18 IMMUNOCOMPATIBLE CORIONIC MEMBRANE PRODUCTS

Family Applications Before (2)

Application Number Title Priority Date Filing Date
ARP110100505A AR080218A1 (en) 2010-02-18 2011-02-18 IMMUNOCOMPATIBLE CORIONIC MEMBRANE PRODUCTS
ARP110100509A AR080222A1 (en) 2010-02-18 2011-02-18 THERAPEUTIC PRODUCTS THAT INCLUDE VITALIZED PLACENTARY DISPERSIONS

Family Applications After (3)

Application Number Title Priority Date Filing Date
ARP110100510A AR080223A1 (en) 2010-02-18 2011-02-18 THERAPEUTIC PRODUCTS THAT INCLUDE VITALIZED PLACENTARY DISPERSIONS
ARP110100507A AR080220A1 (en) 2010-02-18 2011-02-18 IMMUNOCOMPATIBLE AMNIOTIC MEMBRANE PRODUCTS
ARP110100506A AR080219A1 (en) 2010-02-18 2011-02-18 IMMUNOCOMPATIBLE CORIONIC MEMBRANE PRODUCTS

Country Status (6)

Country Link
US (28) US20110206776A1 (en)
EP (10) EP3351625A1 (en)
AR (6) AR080218A1 (en)
CA (6) CA2790322A1 (en)
ES (2) ES2665466T3 (en)
WO (6) WO2011103470A1 (en)

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